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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMCGHAN SALINE-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantALLERGAN
PMA NumberP990074
Supplement NumberS005
Date Received01/29/2001
Decision Date04/09/2001
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new series of sizes for the style 363 saline-filled breast implant. The device, as modified, will be marketed under the trade name mcghan saline-filled breast implants, style 363lf and is indicated for: 1) breast augmentation for women 18 years or older and 2) breast reconstruction.
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